SUMMARY OF PRODUCTS CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Apometic 10mg/ml Solution for Injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains

Active substance

Apomorphine hydrochloride

Excipients

Sodium metabisulphite

For a full list of excipients, see section 6.1.

10 mg

1.0 mg

3.

PHARMACEUTICAL FORM

Solution for Injection

Clear, colourless or almost colourless solution

4.

CLINICAL PARTICULARS

4.1

Target species

Dogs

4.2

Indications for use, specifying the target species

To induce emesis in dogs that have, or are suspected to have, ingested substances that may be poisonous.

4.3

Contraindications

Do not use in cases of depression of the central nervous system.

Do not use in cats and other species.

Do not use in cases of caustic poisoning or where gastric foreign bodies may be present.

Do not use in cases of poisoning due to pyrethroids

Do not use in animals known to be hypersensitive to apomorphine or any other excipients.

4.4

Special warnings for each target species

Do not exceed the recommended dosage. Emesis occurs rapidly (within 10 minutes). If emesis is not induced following a single injection, repeated injections will also prove ineffective and should not be given.

4.5

Special precautions for use

i.

Special precautions for use in animals

Use of the product is not recommended if the poison was ingested, or suspected to be ingested, more than 2 hours previously.

The use of the product in cases of known or suspected hepatic impairment should be in accordance with a risk/benefit assessment by the responsible veterinarian.

ii.

Special precautions for the person administering the veterinary medicinal product to animals

Avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the doctor.

Avoid contact with skin and eyes. In case of contact with skin or eyes, rinse immediately with fresh water.

iii.

Other precautions

None

4.6

Adverse reactions (frequency and seriousness)

Adverse effects include hypotension, drowsiness and/or sedation, dyskinesia and protracted vomiting.

The decrease in blood pressure is dose-dependent. The maximum decrease in blood pressure is normally reached after 5 minutes following i.v. dose and the blood pressure returns to basal level after 10 to 30 minutes.

4.7

Use during pregnancy, lactation or lay

No data are available. Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8

Interaction with other medicinal products and other forms of interaction

Dopamine antagonists (e.g. phenothiazines) may negate the emetic effect of apomorphine.

4.9

Amount(s) to be administered and administration route

Dogs: 0.2 mg per kg bodyweight (0.02 ml/kg bodyweight), by subcutaneous injection.

Weigh animals before treatment.

Use a 1ml syringe graduated to 0.01ml to facilitate accurate dosing

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

Overdose may result in respiratory and/or cardiac depression, CNS stimulation or depression and protracted vomiting. Doses of 0.4 mg/kg - 1.6 mg/kg administered intravenously in dogs resulted in a short period of sedation followed by incessant running lasting from ½ to 1 hour from which the animals recovered. Naloxone may reverse the respiratory and CNS effects of the product but not the emetic effects.

4.11

Withdrawal period(s)

Not applicable

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Dopamine agonists

ATC Vet Code: QN04BC07

5.1

Pharmacodynamic properties

Apomorphine is a synthetic derivative of morphine with no analgesic, opiate or addictive properties. At low doses, apomorphine induces emesis by stimulation of the dopamine receptors in the chemoreceptor trigger zone (CTZ).

Higher doses of apomorphine, however, may suppress vomiting by stimulating the µ receptors in the vomiting centre in the brain.

It may lower blood pressure and body temperature and increase heart rate but these effects are transient. It may also increase cortisol levels, reduce gastrin and insulin levels but these effects disappear within 30-60 minutes.

5.2

Pharmacokinetic properties

Absorption

After subcutaneous administration apomorphine is rapidly absorbed. Concentrations sufficient to induce emesis in the dog are achieved during the first 3-10 minutes and peak plasma concentrations are achieved in 20 to 25 minutes.

Distribution

Apomorphine is lipophilic and it penetrates tissues well. Diffusion across the blood-brain barrier is rapid after injection.

Metabolism

Apomorphine is extensively metabolised by the liver into non-active metabolites.

Excretion

The metabolites and very little unchanged apomorphine (<2%) are excreted via the urine. The half-life of apomorphine in dogs is 30-64 minutes.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium metabisulphite

Hydrochloric acid

Sodium hydroxide

Water for injections

6.2

Incompatibilities

In the absence of compatibility studies, apomorphine must not be mixed with other veterinary medicinal products.

6.3

Shelf life

The shelf life of the veterinary medicinal product as packaged for sale: 3 years.

For single use only. Any unused solution should be discarded.

6.4

Special precautions for storage

Do not store above 25°C.

Store in the original package to protect from light.

The solution should be inspected visually prior to use. Only clear and colourless solutions should be used.

6.5

Nature and composition of immediate packaging

Clear glass (Ph Eur Type I) ampoules containing 2 ml solution for injection, in packs of 2 or 5 ampoules in a cardboard box.

Not all pack sizes may be marketed.

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7.

MARKETING AUTHORISATION HOLDER

Forum Animal Health Limited

Crown House

2-8 Gloucester Road

Redhill

Surrey

RH1 1FH

8.

MARKETING AUTHORISATION NUMBER

Vm 46275/4001

9.

DATE OF FIRST AUTHORISATION

26 April 2013

10.

DATE OF REVISION OF THE TEXT